Phase i clinical study, open-label, randomized, parallel to evaluate the safety of the 200 mg dexibuprofen following single and multiple dose oral administration in healthy participants of both sexes under fasting and fed conditions.
NCT ID NCT02956525
First seen Sep 09, 2026 · Last updated Sep 09, 2026
Summary
Phase I Study to Evaluate the Safety of Dexibuprofen 200mg (Apsen Pharmaceuticals A / S.) After a Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes Under Fasting and Fed Conditions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
52 people
The number who actually took part.
- Started
-
Apr 2018
- Finished
-
Jul 2018
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participant able to understand and sign the informed consent of the study; * Healthy research participant, of both sexes, aged between 18 and 50 years, with BMI between 18.50 and 29.99 kg / m2; * Participant considered healthy by evaluating the medical history, vital signs and general clinical examination; * The results of clinical laboratory tests (biochemistry, hematology, serology, urinalysis and ECG certified by cardiologists) within the normal range established by the laboratory or changes that are considered not clinically significant by study physician. Exclusion Criteria: * History of any major surgery in the last three months; * History present or previous history of any cardiac event, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric, hematologic, considered by the investigator as clinically significant and can endanger the participant's health; * History of chronic alcohol abuse, drugs, drugs and / or smoking in the last 6 months; * Known hypersensitivity to dexibuprofen, ibuprofen or its related (other nonsteroidal anti-inflammatory drugs) as well as components present in the formulation; * History of use of drugs that potentially interfere with the kinetics / dynamics dexibuprofen or any other medication considered clinically significant by the investigator with time less than 7 times of drug half-life preceding the period of inclusion; * Regular consumption of grapefruit and / or their derivatives; * Pregnant women and nursing mothers; * Donation or loss of 450 ml or more of blood within 3 months before the study and / or hospitalization for any reason, up to 4 weeks before the beginning of it. * Participation in any clinical trial in the last 12 months preceding the start of the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy volunteers are added.
By submitting, you agree to our Terms of use
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Azidus laboratories Ltd.
Valinhos, São Paulo, 13271-130, Brazil
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Comparative effects of three breathing techniques on heart rate variability, attention, reaction time, and anxiety in healthy adults: a randomized controlled trial
- An Open-Label phase 1 study to assess the safety, tolerability, and pharmacokinetics of a single dose of a new tablet formulation of TRTL-729 in healthy adults
- A phase 2b, randomized, placebo-controlled, observer-blind study in adults 60 years of age and older to evaluate the efficacy, safety, and immunogenicity of a bivalent protein vaccine candidate against respiratory syncytial virus (RSV) and human metapneumovirus (HMPV)
- THERMOS-LUNCH: effects of meals differing in nutritional quality and environmental footprint on postprandial metabolism, Diet-Induced thermogenesis, respiratory quotient, satiety, and hydration status in healthy young men
- Can a copycat humira match the original?
- Can a common Painkiller's cousin pass the safety test?